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NCT05358834 · ClinicalTrials.gov registry record · NA
Testing Effects of Melatonin on Uterine Contractions in Women
A NA study of Pregnant Women, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT05358834: Recruiting NA study of Pregnant Women, sponsored by Brigham and Women's Hospital.
NCT05358834 is a NA study of Pregnant Women that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 120 participants, below the 1,145-participant average among 5 other Pregnant Women trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05358834, a NA study of Pregnant Women, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
The study will extend recent discoveries that have been made in basic human physiology related to responses melatonin and uterine contractions in late- or full-term pregnant women. The basic physiology work has been conducted in in vitro models of the human myometrium characterizing its responses to melatonin, and in pilot in vivo studies correlating the number of uterine contractions with melatonin concentrations that were manipulated by different types of light exposure. The planned experiments will test a causal link between circulating melatonin levels and uterine contractions in full-term pregnant women by manipulating melatonin levels using exogenous melatonin (i) during the day when endogenous levels of melatonin are very low (Experiment 1), and (ii) during the evening under conditions with lighting that would be expected to suppress the higher evening and nighttime levels of endogenous melatonin (Experiment 2).
Primary Outcome
Daytime: Total number of uterine contractions
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Melatonin
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-01-01 |
| Est. Completion | 2027-06-30 |
| Phase | NA |
What NCT05358834 shows while recruiting
NCT05358834 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,145-participant average among 5 other Pregnant Women trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Pregnant Women appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05358834 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05358834 about?
NCT05358834 is a clinical study titled "Testing Effects of Melatonin on Uterine Contractions in Women". The study will extend recent discoveries that have been made in basic human physiology related to responses melatonin and uterine contractions in late- or full-term pregnant women. The basic physiology work has been conducted in in vitro models of the human myometrium characterizing its responses to...
What is the current status of trial NCT05358834?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2023-01-01. Estimated completion is 2027-06-30.
What conditions does trial NCT05358834 study?
This clinical trial studies the following conditions: Pregnant Women.
What interventions are being tested in trial NCT05358834?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Melatonin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05358834?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05358834 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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